SERAQUEST EB VCA IGG

K990410 · Quest Intl., Inc. · LSE · Oct 28, 1999 · Microbiology

Device Facts

• Record ID: K990410
• Device Name: SERAQUEST EB VCA IGG
• Applicant: Quest Intl., Inc.
• Product Code: LSE · Microbiology
• Decision Date: Oct 28, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3235
• Device Class: Class 1

Indications for Use

The EB VCA IgG test is intended for the qualitive and semi-quantative detection of IgG antibodies to Epstein-Barr viral capsid antigen (VCA) in human serum by enzyme immunoassay, as an aid in differentiating active or recent Epstein-Barr virus infection from past infection. For manual use, or for use with the HyPrep System Plus. For In Vitro Diagnostic Use Only.

Device Story

SeraQuest EB VCA IgG is a solid-phase enzyme immunoassay (EIA) for detecting IgG antibodies against Epstein-Barr virus capsid antigen in human serum. Input: human serum sample; process: sample incubation in microwells coated with recombinant p18 antigen; immobilization of specific IgG antibodies; addition of enzyme-labeled goat anti-human IgG conjugate; addition of p-Nitrophenyl phosphate substrate; colorimetric reaction measured via spectrophotometry at 405 nm. Output: Index values representing antibody levels. Used in clinical laboratories by trained personnel. Results assist clinicians in differentiating active/recent Epstein-Barr virus infection from past infection, supporting patient management decisions.

Clinical Evidence

Clinical study compared SeraQuest EB VCA IgG against Gull Laboratories' EBV IgG ELISA using 157 specimens. Results showed 130 positive, 9 negative, and 18 equivocal/discrepant results. Excluding equivocal results, relative sensitivity was 92.2% (95% CI: 87.8-96.6%) and relative specificity was 90.0% (95% CI: 71.4-100%). Overall agreement was 92.1% (95% CI: 87.7-96.4%).

Technological Characteristics

Enzyme immunoassay (EIA) using plastic microwell solid phase. Antigen: recombinant p18. Conjugate: goat anti-human IgG labeled with alkaline phosphatase. Substrate: p-Nitrophenyl phosphate. Stop reagent: 0.5 M Trisodium phosphate. Readout: spectrophotometric at 405 nm. Manual or semi-automated (HyPrep System Plus) operation. Three 30-minute incubation periods at room temperature.

Indications for Use

Indicated for qualitative and semi-quantitative detection of IgG antibodies to Epstein-Barr viral capsid antigen (VCA) in human serum. Used as an aid in differentiating active or recent Epstein-Barr virus infection from past infection. For in vitro diagnostic use; manual or semi-automated (HyPrep System Plus) use.

Regulatory Classification

Identification

Epstein-Barr virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to Epstein-Barr virus in serum. The identification aids in the diagnosis of Epstein-Barr virus infections and provides epidemiological information on diseases caused by these viruses. Epstein-Barr viruses are thought to cause infectious mononucleosis and have been associated with Burkitt's lymphoma (a tumor of the jaw in African children and young adults) and postnasal carcinoma (cancer).

Predicate Devices

• Gull Laboratories' EBV IgG ELISA test

Reference Devices

• HyPrep System Plus

Submission Summary (Full Text)

{0}------------------------------------------------

OCT 2 8 1999

APPENDIX 3.

Quest International, Inc., 1938 N.E. 148th Terrace, N. Miami, FL 33181 Page No. GAL

K990410

# 510(k) SUMMARY

| Applicant: | Quest International, Inc.<br>1938 N.E. 148th Terrace<br>North Miami, FL 33181 |
|------------------------|-------------------------------------------------------------------------------|
| Registration No. | 1061839 |
| Contact Person: | Robert A. Cort, V.P., Quality Assurance |
| Telephone: | [phone] |
| Telefax: | [phone] |
| Manufacturing Site: | Same as above |
| Device: | SeraQuest® EB VCA IgG |
| Device Name: | Epstein-Barr virus serological reagents (21CFR § 866.3235) |
| Device Classification: | Class I (general controls) |

### ascription:

The SeraQuest EB VCA IgG test is a solid-phase enzyme immunoassay (EIA), which is performed in microwells, at room temperature, in three thity minute incubations. It has been developed in
IgG antibodies which are directed against Enotein Romains. It has been develope look to the superialism (in throe thirty minute incubations. It nas been developed to

The Calibrators in the SeraQuest EB VCA IgG test set have been assigned Index values based on an in-house standard. Test results are reported as Index values.

# Principle:

Diluted samples are incubated in wells coated with Epstein-Barr virus capsid antigen. Antibodies directed against Epstein-Barr virus capsid antigen (if present) are immobilized in the wells. Residual sample is eliminated by washing and draining and online in the well. Hesidual human IgG) is added and including to Epstein-Barr virus capsid antibodies to
human IgG) is added and incubated. If IgG anibodies to Epstein-Barry present, the conjugate will be immobilized in the wells. Residual conjugate is eliminated by washing and draining, and the enzyme substrate is added and incubated. In the presence of the the substrate is converted to onlymo oubstrate is added and incubation. In the presence of the substrate

### Intended Use:

tended Use: The EB VCA IgG test is intended for the qualitive and semi-quantative detection of in of the collection of or rigated in ine qualified and semi-quantative defection of any

{1}------------------------------------------------

munoassay, as an aid in differentiating active or recent Epstein-Barr virus infection from past nfection. For manual use, or for use with the HyPrep System Plus. For In Vitro Diagnostic Use Only.

# Predicate Device:

The SeraQuest EB VCA IgG test is substantially equivalent in intended use and performance, to the Gull Laboratories' EBV IgG ELISA test, Gull Laboratories, Inc., Salt Lake City, Utah.

# Summary of technological characteristics:

| Characteristic | SeraQuest EB VCA IgG | Gull Laboratories ' EBV IgG ELISA |
|-----------------------------------|-----------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|
| Description: | Enzyme Immunoassay | Enzyme Immunoassay |
| Intended Use: | The detection of IgG<br>antibodies against Epstein-<br>Barr virus capsid antigen<br>in human serum. | The detection of IgG<br>antibodies against Epstein-<br>Barr virus capsid antigen<br>in human serum. |
| Solid Phase: | Plastic Microwell | Plastic Microwell |
| ntigen : | Recombinant p18 | Purified gp 125 |
| Number of Incubation Periods: | Three | Three |
| Sample Dilution: | 1:50 | 1:21 |
| Sample Incubation<br>Duration: | 30 minutes | 30 minutes |
| Incubation Temperature: | Room temperature | 37 °C. |
| Ezyme-labeled Conjugate: | | |
| Antibody | Goat anti-human IgG | Goat anti-human IgG |
| Enzyme | Alkaline phosphatase | Alkaline phosphatase |
| Conjugate Volume: | 100 ul | 100 ul |
| Conjugate Incubation<br>Duration: | 30 minutes | 30 minutes |
| Substrate: | p-Nitrophenyl<br>phosphate | p-Nitrophenyl<br>phosphate |

{2}------------------------------------------------

| APPENDIX 3. | Quest International, Inc., 1938 N.E. 148th Terrace, N. Miami, FL 33181<br>Page No. 86 | |
|-----------------------------------|---------------------------------------------------------------------------------------|------------------------------|
| ubtrate Volume: | 100 μl | 100 μl |
| Substrate Incubation<br>Duration: | 30 minutes | 30 minutes |
| Stop Reagent: | 0.5 M Trisodium<br>phosphate | 1.5 N Sodium<br>hydroxide |
| Stop Reagent Volume: | 100 μl | 100 μl |
| Readout: | Spectrophotometric<br>405 nm | Spectrophotometric<br>405 nm |

Summary of Clinical Testing:

Of the 157 specimens tested, 130 were positive, and 9 were negative in both the SeraQuest and Of the 157 specimens tested, 130 were positive in of remains and the many of in Gull Laboratories tests (please see Table by the SeraQuest test, and 11 specimens which were was negative by the Gull test, was postive by the SeraQuest test. Six specimens gave equivocal results
positive by the Gull test, were negative by the SeraQuest test. Six spe positive by the Gulf test, were nogalive by the been see Table 1 below.

## TABLE 1.

.ESULTS OF SeraQuest EB VCA IgG ASSAYS, AND GULL VCA IgG ASSAYS, OF .ESULTS OF Seraudes EB VCA Titles TESTS WERE PERFORMED IN-HOUSE AT QUEST INTERNATIONAL, INC., MIAMI, FL.

| GULL<br>VCA<br>IgG | SeraQuest EB VCA IgG | | | | | |
|--------------------|----------------------|-----------|----------|-----------------------|------|--------------|
| | Positive | Equivocal | Negative | | % | 95 % CI |
| Positive | 130 | 2 | 11 | Relative sensitivity* | 92.2 | 87.8 to 96.6 |
| Equivocal | 2 | 1 | 0 | Relative specificity* | 90.0 | 71.4 to 100 |
| Negative | 1 | 1 | 9 | Overall agreement* | 92.1 | 87.7 to 96.4 |

* Excluding equivocal results.

V Calculated by the normal method.

Reference: Gardner, M.J. and Altman, D.G., Confidence Intervals Rather Than Hypothesis Testing. Brit. Med. J., 292: 746-750, 1986.

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the bird symbol.

OCT 2 8 1999

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Robert A. Cort Vice President, Quality Assurance Quest International, Inc. 1938 N.E. 148th Terrace North Miami, Florida 33181

Re: K990410 Trade Name: SeraQuest EB VCA IgG Regulatory Class: I Product Codc: LSE Dated: August 12, 1999 Received: September 8, 1999

Dear Mr. Cort:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment datc of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice rcquirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Eederal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

{4}------------------------------------------------

Page 2

Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at [phone].

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll free number [phone] or at [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"

Sincerely yours,

Steven Autman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

Quest International, Inc., 1938 N.E. 148th Terrace, N. Miami, FL 33181 Page No. (UC

#### APPENDIX 6

Page 1 of 1

510(k) Number (if known): ________

Device Name: SeraQuest EB VCA IgG

Indications For Use:

- 1. For in vitro diagnostic use only.
- 2. For the qualitative and semi-quantitative detection of IgG antibodies to Epstein-Barr viral capsid antigen (VCA) in human serum by enzyme immunoassay.
- 3. For use as an aid in differentiating active or recent infection, from past infection.
- 4. For manual use, or for use with the HyPrep System Plus semi-automated fluid handler.

# (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Woody Dubois

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K990410

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)